BridgeBio Pharma
biopharma
AssociateDirector,RegulatoryAffairsCMC
“Associate Director, Regulatory Affairs - CMC at BridgeBio Pharma. Skills: Regulatory Affairs CMC, global CMC regulatory strategies, regulatory submissions, CMC sections of regulatory dossiers, Health Authority interactions. manage internal regulatory processes. prepare documents for regulatory submissions in compliance with global health authority regulations”
Industry & Context.
Demonstrated ability to leverage artificial intelligence tools to support and enhance the execution of complex tasks, improving efficiency, and decision-making quality.
quarterly, or as needed visits to our San Francisco Office.
What They're Looking For.
Must Have
minimum of a bachelor’s degree is required (life sciences discipline preferred), Minimum of 7 years experience in pharmaceutical or related industry in regulatory affairs, CMC or related function, eg, drug development/manufacturing/QC/QA (an equivalent combination of education and experience may be considered), Excellent communication skills and attention to detail, Independently able to manage projects and deliver output in a timely manner with limited direction of manager, Excellent computer skills, e. g. , Microsoft suite of applications/software and document management system such as Veeva, Demonstrated self-starter with the ability to take initiative, work independently, and proactively identify and execute tasks with minimal supervision., Excellent interpersonal, active listening, and influencing skills, Demonstrated ability to leverage artificial intelligence tools to support and enhance the execution of complex tasks, improving efficiency, and decision-making quality.
Nice to Have
life sciences discipline preferred
What You'll Do.
manage internal regulatory processes
prepare documents for regulatory submissions in compliance with global health authority regulations
Develop global CMC regulatory strategies in collaboration with manager and CMC subject-matter experts to meet business objectives for the Eidos program
create and prepare CMC sections of regulatory dossiers marketing applications (ROW)
prepare and communicate timelines
coordinate preparation of the CMC sections
review and approval workflows
Provide recommendations to team on regulatory strategy as needed
RA CMC support for Health Authority interactions
including coordination of drafting and reviewing meeting requests and briefing books.
strategy and responses to Health Authority CMC questions (ROW)
support from triage through finalization of regulatory responses
input to team on regulatory strategy as needed
Maintain current knowledge of applicable global regulations
guidance and standards for drug development and product registration
Other duties as assigned.
How You'll Work.
Team & Collaboration
collaborate and interact with various departments and levels of management, including interactions across BridgeBio subsidiaries; Collaborate with cross-functional teams (e. g. Regulatory Int. ); represent regulatory affairs CMC as part of an interdisciplinary team
Communication Scope
Excellent communication skills; Excellent interpersonal, active listening, and influencing skills
Process & Methodology
Independently able to manage projects and deliver output in a timely manner with limited direction of manager
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